LONDON, November 13, 2014 /PRNewswire/ --
Norgine today announced the enrolment of the first patients into two European Phase III studies (MORA and DAYB) for its investigational product NER1006. The MORA study will evaluate the bowel cleansing efficacy* of NER1006 versus MOVIPREP® using a 2-day split-dosing regimen and a 1-day morning split-dosing regimen in adults. The DAYB study will also evaluate the efficacy* of NER1006 versus a sodium picosulfate and magnesium salt solution (CITRAFLEET®) using a day before only dosing regimen in adults. The MORA and DAYB studies will also assess the compliance, safety, patient acceptability and tolerability of NER1006.
NER1006 is a novel, low volume polyethylene glycol based bowel preparation that has been developed to provide whole bowel cleansing, with an additional focus on the ascending colon. The dosing regimen of NER1006 (1 L**, of bowel preparation solution with 1 L** of extra water or clear fluid) aims to deliver a high level of efficacy. This low volume solution is developed not only to support improved patient acceptability and compliance but also to contribute to effectiveness of colonoscopy procedures at detecting colon cancer and for optimised bowel surveillance, through effective bowel cleansing.
The MORA and DAYB studies are part of Norgine's NER1006 Phase III clinical trials programme. Both MORA and DAYB are European*** multicentre, randomised, parallel-group clinical trials that are expected to enrol approximately 1,294 patients in total. The Phase III programme also includes a clinical study in the United States, NOCT, which will compare NER1006 versus a trisulfate bowel cleansing solution (SUPREP®) using a 2-day split-dosing regimen in adults. Enrolment for the NOCT trial commenced in September 2014.
Donna McVey, Chief Development Officer, Norgine, commented: "We are pleased that the first patients have now been enrolled into the European studies which aim to demonstrate that NER1006 can improve patient acceptability and compliance. These pivotal trials complement the data already available for this novel preparation, and further strengthen our bowel cleansing portfolio."
See full release on http://www.norgine.com
1. Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations From the US Multi-Society Task Force on Colorectal Cancer. A joint guideline from the American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy. The American Journal of Gastroenterology. 2014
Charlotte Andrews: Tel: +44-(0)1895-453669, Mob: +44-(0)7714-061485
Peter Martin: Tel: +44-(0)1895-453744, Mob: +44-(0)7799-078744
SOURCE Norgine B.V.